NCT02498418

Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

Completed Phase 3 Results posted Last updated 5 December 2019

What this trial tests

Phase 3 trial testing Rifaximin in Diarrhea in 739 participants. Completed in 28 February 2017.

Timeline

6 January 2016

Primary endpoint
28 February 2017

28 February 2017

Quick facts

Lead sponsor	Actavis Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	739
Start date	6 January 2016
Primary completion	28 February 2017
Estimated completion	28 February 2017
Sites	1 location across United States

Drugs / interventions tested

• Rifaximin (rifaximin) — full drug profile →
• Xifaxan®
• Placebo Tablet

Conditions studied

• Diarrhea — all drugs for Diarrhea →

Sponsor

Actavis Inc. — full company profile →

Who can join

18 and older, any sex, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population Primary · TOC visit (Day 5, 6 or 7)

Clinical cure was defined as either of the following: No stools or only formed stools within a 48-hour period and no fever, with or without other enteric symptoms or; No watery stools or no more than 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Bioequivalence evaluation between test (generic rifaximin 200 mg tablets) and reference groups (xifaxan 200 mg tablets) was conducted in this endpoint, hence placebo group was not included. Participants who were discontinued early from the study due to lack of treatment e

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	90
Xifaxan 200 mg Tablets	93

Time to Last Unformed Stool (TLUS) Secondary · Day 1 to Day 5

TLUS was defined as the interval beginning with the first dose of study drug and ending with the last unformed stool passed within a period of 120 hours (within 48 hours from the time of last dose \[at 72 hours\]). Mathematically, TLUS was calculated as follows. TLUS (hours) = date/time of last unformed stool within 48 hours from the time of last dose - date/time of first dose.

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	65.25	3.93 – 119.42
Xifaxan 200 mg Tablets	65.75	14.10 – 117.08
Rifaximin Placebo Tablets	67.01	16.65 – 117.87

Percentage of Participants Who Achieved Microbiological Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose) Secondary · TOC visit (Day 5, 6, or 7)

Participants were considered to have achieved microbiological cure if the pathogen identified at Day 1 is no longer found in the stool at the TOC visit.

Escherichia coli

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	25.5
Xifaxan 200 mg Tablets	31.9
Rifaximin Placebo Tablets	17.4

Enterotoxigenic Escherichia coli (ETEC)

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	43.5
Xifaxan 200 mg Tablets	54.5
Rifaximin Placebo Tablets	68.4

Enteroaggregative Escherichia coli (EAEC)

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	32.0
Xifaxan 200 mg Tablets	27.3
Rifaximin Placebo Tablets	26.1

Other microorganisms

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	70.6
Xifaxan 200 mg Tablets	81.8
Rifaximin Placebo Tablets	92.9

Stool microscopy for ova and parasites

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	83.3
Xifaxan 200 mg Tablets	100.0
Rifaximin Placebo Tablets	100.0

Number of Participants Who Achieved Clinical Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose): Modified Intent-to-Treat (mITT) Population Primary · TOC visit (Day 5, 6 ,or 7)

Clinical cure was defined as either of the following: No stools or only formed stools within a 48-hour period and no fever, with or without other enteric symptoms or; No watery stools or no more than 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Participants discontinued early for reasons other than "lack of treatment effect after completing 9 doses within 72 hours from the time of first dose" and for "participants whose condition worsened and who required alternate or supplemental therapy for the treatment of tr

Group	Value	95% CI
Generic Rifaximin 200 mg Tablets	91
Xifaxan 200 mg Tablets	95
Rifaximin Placebo Tablets	86

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to Day 7. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Generic Rifaximin 200 mg Tablets

Serious: 0/246 (0%)

Deaths: 0/246

Xifaxan 200 mg Tablets

Serious: 0/247 (0%)

Deaths: 0/247

Rifaximin Placebo Tablets

Serious: 0/244 (0%)

Deaths: 0/244

Other adverse events (22 terms — click to expand)

Reaction	System	Generic Rifaximin 200 mg T…	Xifaxan 200 mg Tablets	Rifaximin Placebo Tablets
Rectal tenesmus	Gastrointestinal disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Defecation urgency	Gastrointestinal disorders	—	—	—
Lymphocytosis	Blood and lymphatic system disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Dizziness	Nervous system disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Food allergy	Immune system disorders	—	—	—
Seasonal allergy	Immune system disorders	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Protein urine present	Investigations	—	—	—
Urine leukocyte esterase	Investigations	—	—	—
Weight decreased	Investigations	—	—	—
White blood cells urine positive	Investigations	—	—	—

Data from ClinicalTrials.gov NCT02498418 adverse events section.

Sponsor's own description

The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.